BEUDAMED
    FDA Adverse Event Death Summary report: N

    530G INSULIN PUMP

    MDR report key: 3903573 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86356
    Event Type
    Death
    Date Received
    June 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED THE DEATH OF HER HUSBAND. THE LAST BLOOD GLUCOSE READING WAS 216 MG/DL. CUSTOMER HAD A PROCEDURE PERFORM. CUSTOMER WENT TO EMERGENCY ROOM ON THE NEXT DAY DUE TO SWELLING IN ARM. CUSTOMER WAS TO START DIALYSIS. CUSTOMER PASSED AWAY IN THE HOSPITAL. CUSTOMER USED THE NEW INSULIN PUMP FOR TWO DAYS. CUSTOMER DIED OF NATURAL CAUSES. CALLER WILL RETURN THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379190 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death